RESEARCH TRIANGLE PARK, N.C., Dec 5, 2012 – The Hamner Institutes for Health Sciences (http://www.thehamner.org) has announced the establishment of a pre-competitive, multi-organization partnership designed to advance an integrated systems biology approach to toxicity testing research. The Hamner and Brown University will conduct the research. Partners sponsoring the research include Agilent Technologies Inc., Illumina, Dow Chemical, Dow Corning Corporation, ExxonMobil, Unilever and CropLife America member companies. The Long-Range Research Initiative (LRI) of the American Chemistry Council supported earlier stages of this research.

Using several toxicity pathway case studies with the explicit goal of speeding implementation of recommendations from the National Research Council report Toxicity Testing in the 21st Century: A Vision and a Strategy, the partnership will develop human cell-based assays that map and model key cell signaling pathways in order to evaluate dose response. These assays, once validated with prototype chemicals, should enable toxicity testing and risk assessments based solely on in vitro test results, without progressing to toxicity studies in intact animals.

These in vitro-based toxicity testing schemes will speed testing of both important compounds in commerce and new compounds coming into use. More rapid testing will also help assess the backlog of thousands of chemicals for which there is very limited toxicity test data. As these test technologies mature, they could also provide a means to speed drug discovery and drug development by providing assessments of safety far earlier in the drug development process.

“This groundbreaking partnership brings together all the components necessary to take a truly integrated biology approach to 21st century toxicity testing and take advantage of modern biology,” said Dr. William Greenlee, president and CEO of The Hamner Institutes for Health Sciences.

“Our partners in the private sector bring a suite of technologies at the cutting edge of what is technically achievable,” said Dr. Melvin Andersen, project director at The Hamner. “Initiative partners from the chemical industry bring experience in applications of toxicity research results in a regulatory context, an understanding of regulation in both the United States and the European Union and knowledge of relevant human exposure patterns for their products. Our academic and nonprofit partners provide laboratory facilities, computational models, animal test capabilities, and a trained and talented research workforce. These joint contributions will accelerate our work and enable a more thorough biologically-relevant assessment of chemical safety.”

Representing one of the technology partners, Darlene J.S. Solomon, Ph.D., senior vice president and chief technology officer at Agilent Technologies, said, “We are pleased to help demonstrate the feasibility of this toxicity pathway-based approach to assess risks to human health. We welcome collaboration with additional federal agencies and industry partners to accelerate the development of new technologies and tools to facilitate next-generation research, and with academic thought leaders to discover new approaches that ensure scientific and technical rigor.”

Research outcomes from this initiative dovetail with the other efforts currently underway, including the Tox-21 Consortium (Tox21C), a collaborative research effort between the Environmental Protection Agency, the National Institutes of Health (NIH), and the Food and Drug Administration. The project also leverages the NIH-funded consortium effort to map estrogenic pathways in human breast cancer cells, led by Dr. Thomas Hartung at The Johns Hopkins University.

A report of a recent review of The Hamner program “Toxicity Testing in the 21st Century: Toxicity Pathways and Network Biology” is available at www.thehamner.org/tt21c and provides a synopsis of the first prototype pathways serving as examples of this integrated systems biology approach to toxicity testing.

The Hamner Institutes for Health Sciences is a nonprofit translational biomedical research institute located on an open, multidisciplinary campus in North Carolina’s Research Triangle Park. Building upon 35 years of research excellence in toxicology, The Hamner works on drug and chemical safety in collaboration with academic, corporate and government partners. Novel technologies used at The Hamner include genomic and bioinformatic approaches for improving toxicity testing, in silico models for predictive toxicology, in vitro models that utilize human cells or cell lines to evaluate perturbations of cellular responses, and in vivo models to elucidate genes that play a role in susceptibility to drug-induced toxicities. For more information, visit http://www.thehamner.org.